|
Device | IDEAL IMPLANT Structured Breast Implant |
Generic Name | Prosthesis, breast, inflatable, internal, saline |
Regulation Number | 878.3530 |
Applicant | Bimini Health Tech 420 Stevens Ave. Suite 220 Solana Beach, CA 92075 |
PMA Number | P120011 |
Supplement Number | S022 |
Date Received | 05/27/2021 |
Decision Date | 10/27/2021 |
Product Code |
FWM |
Advisory Committee |
General & Plastic Surgery |
Clinical Trials | NCT00858052
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to the patient and physician labeling including a boxed warning and a patient decision checklist. |
Approval Order | Approval Order |